BICR in New Therapeutic Lung Cancer Trials

Lung Cancer Clinical Trial

Official title:

Blinded Independent Central Review (BICR) in New Therapeutic Lung Cancer Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05038826
• Other study ID #: Median202101
• Status: Completed
• Start date: February 1, 2021
• Est. completion date: December 1, 2021

Study information

• Verified date: March 2023
• Source: Median Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Double reads in blinded independent central reviews (BICRs) are recommended to control the quality of trials but they are prone to discordances. We analyzed inter-reader discordances in a pool of lung cancer trials using RECIST 1.1.

Description:

In the past decade, the lung cancer treatment landscape has dramatically evolved, increasingly branching out thanks to better understanding of disease mechanisms of action, novel technologies, and some amount of serendipity in drug development. Today, approximately 2500 clinical trials registered on clinicaltrial.gov are about to recruit or are actively recruiting in order to investigate new therapeutics of lung cancer, offering new hope to patients for better survival and for improvements in quality of life.

Blinded independent central reviews (BICRs) are advocated in clinical trials to in-dependently verify endpoints and control bias that might result from errors in response or progression assessments. In the BICR settings with double reads, the medical images are reviewed by two independent readers blinded to the results of the other reader, the study treatment, the investigator assessment, and some pre-defined clinical information. The double-reading paradigm creates the possibility for discordance between the two readers; therefore, a third radiologist is involved to make the final decision of the evaluation outcome. The monitoring of reader performance is required by regulatory bodies to ensure data quality and reliability. At the trial level, a high adjudication rate could be an alert of poor quality at the study level, and a low number of endorsements from a given reader would raise concerns about the reliability of that specific reader. Therefore, relevant key performance indicators (KPIs) must be designed and implemented before starting the reads; these allow the study monitor to trigger corrective actions accordingly. A pooled analysis of 79 oncology clinical trials showed that the proportion of cases requiring adjudication among the 11 lung cancer trials included in the analysis was 38% (95% CI: 37-40%). However, this study was general to all cancer types and did not included details on discrepancy root cause or recently approved novel therapeutics. Considering the atypical response patterns provided by those drugs, we thought it prudent to provide an update on reader performance specific to new therapeutics in lung cancer.

Focusing on BICRs in assessing novel drugs, the aim of this study was to analyze a pool of lung trials using RECIST 1.1, document the proportion of reader discrepancies, and provide suggestions to aid in improving the read consistency of future trials by estimating relevant KPIs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1833
• Est. completion date: December 1, 2021
• Est. primary completion date: August 10, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patient diagnosed with lung cancer and included in a clinical trial between 2017 and 2021

• trials were conducted with double reads with adjudication, and assessments were based on RECIST 1.1 guidelines

• The central reads performed using the same radiological reading platform (LMS; Median Technologies, France)

Exclusion Criteria:

• reader evaluation with less than 25 adjudications

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Locations

Country	Name	City	State
France	Yan Liu	Valbonne

Sponsors (1)

Lead Sponsor	Collaborator
Median Technologies

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inter-reader discordance rate	Based on the Response Evaluation in Solid Tumors (RECIST), inter-reader discordance rate considering any discordances at any time point: Number of discrepant time points / Total number of time point; Based on the Response Evaluation in Solid Tumors (RECIST), inter-reader discordance rate considering any discordances at any time point: Number of patients with, at least, one discrepant time point/ Total number of patients; Based on the Response Evaluation in Solid Tumors (RECIST), inter-reader discordance rate in reporting, at least, one progressive disease at any time point: Number of patients with, at least, one discrepant time point on PD / Total number of patients	6 months
Secondary	endorsement rate	Readers' endorsement rate from pooled trials as, for each readers, the proportion of adjudication in their favor	6 months
Secondary	adjudication rationale	Proportion of deemed "errors" and "medically justifiable differences" after adjudication	6 months
Secondary	Correlation between discrepancy rate and timepoints	Correlation between discrepancy rate and the average number of time points per patient	6 months
Secondary	root cause	Reasons for adjudications after root cause analysis	6 months